Biocon, Mylan seek FDA approval for trastuzumab biosimilar

Mylan has submitted a biologics license application (BLA) for MYL-1401O via the 351(K) pathway.

The proposed biosimilar version of trastuzumab is indicated to treat several breast and gastric cancers.

The companies said they believed that their application has the potential to be the first submission of a proposed biosimilar trastuzumab in the US.

Mylan’s BLA includes a package of analytical similarity, nonclinical and clinical data, which features two pharmacokinetic studies and the Heritage confirmatory efficacy and safety trial.

MYL-1401O is one of the six biologic products co-developed by Mylan and Biocon for the worldwide marketplace.

Mylan has exclusive commercialization rights for MYL-1401O in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.

Biocon holds co-exclusive commercialization rights with Mylan for the product in the remaining parts of the world.

Biocon CEO & joint MD Arun Chandavarkar said: "The submission of our proposed biosimilar trastuzumab with the U.S. FDA is an important milestone of Biocon and Mylan's joint global biosimilars program and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe.

“Cancer patients in India and emerging markets have benefited with our trastuzumab and this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools."

The companies recently announced that the European Medicines Agency has accepted for review Mylan's marketing authorization application for insulin glargine, a long-acting insulin analog used for the treatment of adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.

Image: Biocon building. Photo: courtesy of Biocon.